TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 868 - ANESTHESIOLOGY DEVICES

subpart c - MONITORING DEVICES

868.2375 - Breathing frequency monitor.

  (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits.

This device does not include the apnea monitor classified in 868.2377.

  (b) Classification. Class II (performance standards).

[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]